Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AY0022

Study information

Scientific title

A new strategy of continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a controlled trial

Acronym

Study hypothesis

1. The frequency of relapse of depressive symptoms will be lower in the group with concomitant antidepressant treatment after the 4th electroconvulsive therapy (ECT) compared to the group taking placebo. 2. The frequency of relapse of depressive symptoms will be lower in the group with concomitant antidepressant treatment after the 4th ECT compared to the group taking antidepressant treatment after the 8th ECT.

Ethics approval

Approved by the Dokuz Eylul University Institutional Review Board, Izmir, Turkey on 03/10/2002 (version 0.0). Amendments were approved on the following dates:Version 0.1: 16/07/2003Version 0.2: 03/10/2004

Study design

Randomised, double-blind, placebo-controlled, parallel-arms trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major depressive disorder

Intervention

Consented subjects who met the inclusion and exclusion criteria were consulted by an anesthesian and cardiologist before starting ECT. Each subject received 8 effective bilateral ECT at a frequency of twice a week.

After completion of 4th ECT session, the participants were randomly allocated to the following three arms:

On the day of randomisation C-Pharm Early group was given sertraline hydrochloride (150 mg/day); C-Pharm Late group was first given identical placebo tablets, which was then substituted with sertraline hydrochloride (150 mg/day) after the completion of the 8th ECT. C-Pharm Placebo group was administered identical placebo tablets throughout the interventions.

Participants were evaluated weekly during the first 4 weeks, then biweekly by Montgomery-Asberg Depression Rating Scale (MADRS) throughout the study period. After the completion of the 8 ECTs, remitters in each study group were identified. To be defined as remitted, patients had to achieve a maximum score of 12 in MADRS.

Intervention type

Drug

Phase

Not Specified

Drug names

sertraline hydrochloride

Primary outcome measure

Rate of relapse. The criterion for relapse was a mean MADRS score of at least 16 that is maintained over 2 consecutive visits.